16. malin fladvad - uppsala monitoring centre

WHO Program for International Drug Monitoring: Global Pharmacovigilance of Biological products

Dr Malin Fladvad, Head of Production

Uppsala Monitoring Centre

WHO Collaborating Centre for International Drug Monitoring

Latin America Conference on Biotherapeutic Medicines Experience:

Sharing Experiences and Best Practices

Nov 19-20, 2013, Lima, Peru

Malin Fladvad, Uppsala Monitoring Centre

UMC’s vision and main tasks

Improve worldwide patient safety and welfare by reducing the risk of

medicines

Collect and analyse

individual case safety reports (ICSRs)

worldwide

Communicate potential

patient safety issues

Actively support and provide training in Pharmacovigilance

Develop the science and practice of

Pharmacovigilance


Individual Case Safety Report (ICSR)

VigiBaseTM


VigiBaseTM quality aspects

A combination of quantative and qualitative measures

Quantity of ICSRs

Up-to-date ICSRs Quality of ICSRs

Each report is valuable!

Structured

Complete

Correct


The UMC signal detection process

Clinical assessment: Review Panel

(or UMC)

Pharma Company

’Follow-up’ or ’Not signal’ Triage

Literature check

Potential signals

VigiBaseTM

National Centre


Improved adverse drug interaction signal detection

• Inclusion of clinical information and pharmacological characteristics give clear performance improvement over previous methods

Identification of previously unknown risks.


WHO Drug Dictionaries


VigiBaseTM VigiLyze

National Centre

VigiFlowTM

Users of WHO Drug Dictionaries

Doctors & Patients

http://www.google.com/url?sa=i&rct=j&q=fabrik+symbol&source=images&cd=&cad=rja&docid=b2NgxbCn9fBL8M&tbnid=eelwkcN7e-2w7M:&ved=0CAUQjRw&url=http://pixers.de/bilder-und-poster/suchen/sw&ei=Z_U9UYylHMfe4QS9uIGIAw&bvm=bv.43287494,d.bGE&psig=AFQjCNEpUVa-buP4YhWmoE0POMx1RMevrw&ust=1363101316220819


WHO Drug Dictionaries

• A source of international drug (trade) names

260 000 product namnes 2 million entries


ICSR mapping


The WHO Drug Dictionaries holds standardised medicinal information

• Trade name

• Active ingredient(s)

• Ma Holder

• Form

• Strength

• Country of sales

• ATC


WHO DD DRL

WHO DDE

WHO DDE+

HD

DDC

CRT Japan

SDGs

The WHO Drug Dictionaries


Product types in the WHO Drug Dictionaries

– Conventional drugs (Arinate, Cetamol)

– Biologicals (monoclonal antibodies, biosimilars, blood products, vaccines etc)

– Herbal products

– Chemotherapy regimens

– Radiopharmaceutical diagnostics

– Generic products

– Substance and substance synonyms


Coding using the WHO Drug Dictionaries

Reditux

Mabthera Kikuzubam

Rituximab

Rituxan

Tidecron


Reditux

Mabthera Kikuzubam

Rituximab

Rituxan

The added value of WHO Drug Dictionaries

Tidecron


WHO Drug Dictionary structure using current WHO Policy (INN)

Reference product

Biosimilar

Active substance,

Biosimilar

Reference product


Some Biosimilars have the same nonproprietary name as reference

product

No discrimination between Reference product and Biosimilar when only drug substance is reported

– Signal analysis

– Coding concomittant medication in clinical trials.

Reference product

Biosimilar

Active substance,

Biosimilar

Reference product


ICSR Reports on biotherapeutics in VigibaseTM

Drug group Number of ICSR

Biotherapeutics 1 531 822

All 8 480 965


ICSR per year reported on biotherapeutics with biosimilars in

VigibaseTM

0

10000

20000

30000

40000

50000

60000

Rituximab Etanercept Somatropin Filgrastim Infliximab


ICSR per regional area reported on biotherapeutics with biosimilars in

VigibaseTM

0

50000

100000

150000

200000

250000

Africa LatinAmerica

NorthAmerica

Asia Europe Oceania



Product classification

Innovation 1 Later innovation Loss of exclusivity Further innovation

Timeline

Reference product Non-

Referenced product

Biosimilar Patent protected product


ICSR reported on biotherapeutics with biosimilars in VigibaseTM

0%

20%

40%

60%

80%

100%


Biosimilar

Non-Ref product

Ref product

Active substance


ICSR reported on biotherapeutics with biosimilars in VigibaseTM

0

10000

20000

30000

40000

50000

60000

Drug substance

Trade name



Reasons for underreporting

• Lack of information

• Lack of understanding

• Lack of time

• Lack of routines

• ADR already known

• Uncertain causality

• Failure to recognize ADR

• Patient confidentiality concern

• Fear of legal liability

• Forgetfulness


Thank you for your attention!

[email protected]

16. malin fladvad - uppsala monitoring centre

Health & Medicine